Whitford’s medical group seeks ISO 13485 certification

The Medical Group is located at the company headquarters in Elverson, Pennsylvania, and will occupy a newly constructed high-tech facility.

The medical group will be dedicated to the use of high-performance fluoropolymer coatings on medical devices. Fluoropolymer coatings have been used on medical devices for many years and offer a variety of benefits. With the new medical group Whitford will seek ISO 13485 quality certification on their coatings.

Dave Willis, founder and CEO of Whitford, said: “As a raw-material supplier for catheter guide-wire manufacturers and coaters, as well as countless biocompatible devices, we understand the benefits of ISO-certification for all global tiers of the medical market. Our dedicated medical-coatings group will enable us to support the use of our coatings in medical applications, and to be a reliable, safe supplier to medical-device manufacturers.”

Greg Lundell, industry manager of medical coatings for Whitford, said: “ISO 13485 outlines the standard quality management system in the medical-device supply chain. Complying with this international standard will allow us and, more important, our customers, to meet global regulatory requirements.”

Investment in the new facility includes new, dedicated equipment, as well as a separate quality-control laboratory with management and operations personnel.

Lundell also said: “Our aim is to become a global leader in medical-coating supply. Having a dedicated facility reinforces our policy of providing exceptional quality and security of supply at a time when many other coating manufacturers are struggling to meet the rising regulatory demands of the medical industry.”